A Phase I, Placebo-Controlled, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Thalidomide in Subjects With HIV-1 Infection
A protein in the blood called tumor necrosis factor (TNF-alpha) is abnormally elevated in
patients with HIV infection and may cause the body to produce more virus. In vitro studies
have demonstrated that thalidomide reduces TNF-alpha levels and inhibits production of HIV.
However, more information on the pharmacological and immunological aspects of thalidomide is
needed.
Patients are randomized to receive oral thalidomide or matching placebo (3:1) at one of
three dose levels daily for 8 weeks. All 12 patients at a dose level must receive treatment
for at least 2 weeks before dose escalation in subsequent patients occurs. The MTD is
defined as the dose level immediately below that at which 3 or more of 9 patients receiving
thalidomide experience dose-limiting toxicity. Patients are followed for a total of 16
weeks.
PER 6/20/95 AMENDMENT: Patients in cohort 1 should discontinue the previous 50 mg
formulation of thalidomide once the new formulation is available. Those patients may either
wash out for 4 weeks and recommence the study or discontinue the study.
Interventional
Endpoint Classification: Pharmacokinetics Study, Masking: Double-Blind, Primary Purpose: Treatment
Teppler H
Study Chair
United States: Federal Government
ACTG 267
NCT00000812
July 2000
Name | Location |
---|---|
University of Colorado Hospital CRS | Aurora, Colorado 80262 |
University of Minnesota, ACTU | Minneapolis, Minnesota |
Memorial Sloan-Kettering Cancer Ctr. | New York, New York 10021 |
Unc Aids Crs | Chapel Hill, North Carolina 27599 |
Case CRS | Cleveland, Ohio 44106 |
Hosp. of the Univ. of Pennsylvania CRS | Philadelphia, Pennsylvania 19104 |